<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201121049453N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-27</date_registration>
      <primary_sponsor>University of Kurdistan</primary_sponsor>
      <public_title>The effect of Resistance Training with Creatine Monohydrate Supplementation on Oxidative Stress and Antioxidant  Indices</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of 8 Weeks of Resistance Training with Creatine Monohydrate Supplementation on Oxidative Stress and Antioxidant  Indices in Older Adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple randomization: First each subject will be taken in each groups (A or B) by tossing a coin. Each side of the coin determines the assignment of each subject. Then each group will be named as control or experimental group by tossing a coin, Blinding description: First, the subjects in the experimental group are randomly divided into two groups: resistance training + creatine monohydrate supplement and resistance training + placebo. The subjects will not know in which group they are.
Creatine monohydrate  and placebo  were identical in amount, taste, texture, color, and appearance. The supplement packages were coded so that neither the investigators nor the participants were aware of the contents until completion of the analyses. The supplements were provided by a staff member of research team who did not have any participation in the data acquisition, analyses, and interpretation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Resistance training.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 15 participants as a resistance training + creatine monohydrate supplement group received 0.1g•kg/day of creatine (under license from Canada, Gene Star Company and approved by the Ministry of Health of Iran) every day for 8 weeks. subjects consumed the supplement as a single dose after training session (similar time in non training dayes).  The supplement packages were coded so that neither the investigators nor the participants were aware of the contents until completion of the analyses. The supplements were provided by a staff member of research team who did not have any participation in the data acquisition, analyses, and interpretation. The training protocol will consist of 3 sets of 10 reps at 75% of 1RM. Resting time between sets and movements were performed for 2 and 3 minutes , respectively. Blood sampling will be performed 48 hours before the start of training and 48 hours after the last training session in the fasting state. Intervention 2: Intervention group 2: 15 participants as a resistance training + placebo group did resistance training for 8 weeks. The training was consist of 3 sets of 10 reps at 75% of 1RM. Resting time between sets and movements were performed for 2 and 3 minutes , respectively. Creatine and placebo (Globe Plus 10 DE Maltodextrin, Univar Canada) were identical in amount, taste, texture, color, and appearance. Fasting blood sampling were taken 48 hours before the training and 48 hours after the last training session. Intervention 3: Control group: 15 participant as control group were asked not to participate in any exercise program and keep on their regular diet during research and report any changes in their life like disease, serious stress.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All  Data

When:
6 months after data publication

To whom:
Student and academic staff

Conditions:
every analyses is fine for future research

Where to obtain:
researcher

How to obtain:
By sending email to researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran boulevard</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۷۷-۱۵۱۷۵</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>ehsan.amiri93@gmail.com</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Sheikholeslami-Vatani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran boulevard</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۷۷-۱۵۱۷۵</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>d.vatani@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 55-70 years old</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Back pain
History of lumbar surgery
Cardiovascular disease
Metabolic sickness history
Clinical limitations for sports activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93.B</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Activities involving other muscle strengthening exercises</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 15 participants as a resistance training + creatine monohydrate supplement group received 0.1g•kg/day of creatine (under license from Canada, Gene Star Company and approved by the Ministry of Health of Iran) every day for 8 weeks. subjects consumed the supplement as a single dose after training session (similar time in non training dayes).  The supplement packages were coded so that neither the investigators nor the participants were aware of the contents until completion of the analyses. The supplements were provided by a staff member of research team who did not have any participation in the data acquisition, analyses, and interpretation. The training protocol will consist of 3 sets of 10 reps at 75% of 1RM. Resting time between sets and movements were performed for 2 and 3 minutes , respectively. Blood sampling will be performed 48 hours before the start of training and 48 hours after the last training session in the fasting state.</i_keyword>
      <i_keyword>Intervention group 2: 15 participants as a resistance training + placebo group did resistance training for 8 weeks. The training was consist of 3 sets of 10 reps at 75% of 1RM. Resting time between sets and movements were performed for 2 and 3 minutes , respectively. Creatine and placebo (Globe Plus 10 DE Maltodextrin, Univar Canada) were identical in amount, taste, texture, color, and appearance. Fasting blood sampling were taken 48 hours before the training and 48 hours after the last training session.</i_keyword>
      <i_keyword>Control group: 15 participant as control group were asked not to participate in any exercise program and keep on their regular diet during research and report any changes in their life like disease, serious stress</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde (MDA). Timepoint: Before and after 8 weeks resistance training. Method of measurement: By ELISA method.</prim_outcome>
      <prim_outcome>Glutathione peroxidase (GPX). Timepoint: Before and after 8 weeks resistance training. Method of measurement: By ELISA method.</prim_outcome>
      <prim_outcome>Total antioxidant capacity (TAC). Timepoint: Before and after 8 weeks resistance training. Method of measurement: By ELISA method.</prim_outcome>
      <prim_outcome>8-hydroxy-2' -deoxyguanosine (8-OHdG). Timepoint: Before and after 8 weeks resistance training. Method of measurement: By ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle strength. Timepoint: Before and after 8 weeks resistance training. Method of measurement: One Repetition maximum.</sec_outcome>
      <sec_outcome>Blood Creatinine. Timepoint: Before and after 8 weeks resistance training. Method of measurement: Blood sampling.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before and after 8 weeks resistance training. Method of measurement: Questionnaire (SF-36) Quality of Life.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before and after 8 weeks resistance training. Method of measurement: weight(kg)/height(m2).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Kurdistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-06</approval_date>
        <contact_name>Ethics commitee of Kurdistan University</contact_name>
        <contact_address>Pasdaran boulevard Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
